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Congenital DisordersNCT00268008

Children and Adolescents Receiving Mechanical and Prosthetic Valves

An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial endocarditis (SBE), structural failure or… Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Congenital Disorders
How many people
300 participants
Where
1 siteUnited States
Study dates
Jan 1976to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Valve replacement in the mitral or aortic position
  • replacement at Children's Healthcare of Atlanta
  • replacement between 1976 and 2002
  • implants may be mechanical, bio-prosthetic or homograft

Who cannot join

  • those who do not meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Retrospective Review of Children and Adolescents Receiving Mechanical and Prosthetic Valves in the Aortic and Mitral Position 1976-2002

The primary objective of this retrospective study of valve replacement is to document long-term survival and occurrence of valve related complications such as described in the literature; anticoagulant related bleeding event , thromboembolic events, subacute bacterial endocarditis (SBE), structural failure or deterioration , valve thrombosis, explantation and reimplantation with reason, death and death cause, and cerebrovascular accidents either permanent or transient in nature.

Secondary to this is the presumption that mechanical valves have a superior "life expectancy " to bio-prosthetic valves. We plan to look at the time of freedom from re-implantation from different types of valves, factoring in patient age, size ,defect and risk factors.

The information learned from this study may benefit future patients who undergo the Ross procedure by increasing our knowledge of safer and/or more effective techniques.

Read the detailed description

Both Aortic and Mitral valves utilizing bio-prosthetic and/or mechanical valves have been placed in adults since the 1960s.The replacement of these valves in children and adolescents began some 10 years after the first adult valve replacement. The majority of valves replaced in the pediatric cohort are due to either stenosis (narrowing) or incompetancy of the native valve. Valvular stenosis in the pediatric patient is normally of congenital etiology, however, a small percentage can be acquired from an infectious process. Stenosis of a valve impedes blood flow through the native valve orifice. Ventricular enlargement, hemodynamic instability and /or other major organ congestion can ensue if left untreated. Dependant upon the severity of the stenosis and the onset of the dysfunction, intervention may be required at any age (newborn to adult). In order for patients to have adequate blood flow to the systemic circulation (the body), the diseased valve must be replaced. Children with native valve stenosis experience failure to thrive, frequent pneumonia, difficulty breathing and generally poor physical development.

If the stenosis is of a critical nature greatly affecting hemodynamics, infants require intervention in the first few days of life. In these patients, initially many of the stenotic valves can be opened in the heart catheterization lab with a procedure called a valvuloplasty. While this procedure does open the valve leaflet apparatus, close approximation of the leaflets is not achieved and a residual insufficiency or regurgitation is present. Most infant hearts can handle minimal resurgent volumes from the resulting cardiac chamber enlargement. It will be necessary to surgically replace the incompetent valve with a prosthetic valve as the child grows. If valvuloplasty is unsuccessful, surgical intervention is required to relive the valvular Stenosis and improve hemodynamics.

Heart valve insufficiency creates a resurgence of blood back into either the left atrium or ventricle causing increased cardiac workload and dilation of the respective chamber of the heart. Incompetence of the Aortic valve will eventually cause congestive heart failure and/or sudden death from arrhythmias.

The initial surgery is dependant on the size of the ventricle and any other concomitant defects the child may have. A ventricle that is too small to support circulation will not be changed by placement of a valve. These patients require staged surgeries for single ventricle palliative repairs. Two examples of congenital cardiac defects include aortic stenosis and cleft mitral valve. If the aortic valve is stenosed and both ventricles are of adequate size, a Ross procedure can be done, The Ross procedure uses the patient's resected native pulmonary valve and main pulmonary artery in place of the aortic valve and outflow tract. A cryo-preserved homograft is then placed in the native pulmonary artery position. This homograft can be implanted with or without a valve dependant upon the patient's size and/or native valve orifice. Mitral valve anomalies occur frequently in patients with Atrioventricular septal defects. With this congenital defect the mitral valve may be dysplastic, or has a cleft in the anterior valve leaflet. This affects the competency of the valve, allowing regurgitation of blood flow into the left atrium. This increased blood volume in the left atrium will eventually lead to pulmonary hypertension. Because of this risk , repair of Atrioventricular septal defect is normally done between the ages of six and twelve months. Repair of the mitral valve is done at that time, with the knowledge that mitral valve replacement will be likely in the child's future. Repair of a heart valve in a patient of any age is always preferable to replacement; in children this is especially true.

Availability of replacement valves in infant sizes are limited to bio-prosthetic or homograft. Cryo-preserved homografts are made from either porcine and cadaver valves. These are generally used for pediatric patients under the age of two years. Historically homografts develop a significant amount of stenosis/calcification at the suture site. In addition, as the child grows the homograft size remains fixed. Both problems require further replacement.

Implantation of mechanical valves in the older children and young adults is considered as a treatment alternative. However, mechanical valves have inherent complications secondary to the requirement of long-term anticoagulant therapy (blood thinners) and the risk of thromboembolic events. Structural malfunctions of the valve and growth of the patient result in the need for replacement of mechanical valves. Additionally, patient compliance and dosing management can be difficult to control.

Keywords
aortic valve replacement, mitral valve replacement, valvular stenosis, Ross procedure, Homograft valves, Bio-prosthetic valves, Mechanical valves
Medical subject headings
Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startJan 1976

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Retrospective
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268008
Sponsor's protocol ID
05-033
Status last verified
May 2007
First submitted
20 Dec 2005
Last updated
7 May 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2007; AzTrials last refreshed its copy on 7 Nov 2026.

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